|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
apnea risk evaluation system (ares)
|
ADVANCED BRAIN MONITORING, INC.
|
K041662 |
10/14/2004
|
lifescreen apnea
|
DEL MAR REYNOLDS MEDICAL, INC.
|
K042745 |
01/19/2005
|
easynet body position module
|
CADWELL LABORATORIES, INC.
|
K040932 |
07/01/2004
|
cadwell limb movement module
|
CADWELL LABORATORIES, INC.
|
K040986 |
07/01/2004
|
dymedix reusable airflow/snore sensor
|
DYMEDIX, INC.
|
K040069 |
05/05/2004
|
bi-naps nasal airflow and snore transducer
|
SALTER LABS
|
K051313 |
09/15/2005
|
stardust ii
|
RESPIRONICS, INC.
|
K052573 |
12/13/2005
|
sandman pocket
|
EB NEURO, S.P.A.
|
K061996 |
10/03/2006
|
somnoscreen
|
SOMNOMEDICS GMBH & CO. KG
|
K060708 |
01/24/2007
|
apnealink, model 22302
|
RESMED GERMANY INC.
|
K061405 |
07/25/2006
|